I just read two articles that offer different perspectives on the same topic—that 2015 was a record-breaking year for new drugs approved by the Food and Drug Administration (FDA).
From, Pharmaceutical Commerce, a BioPharma business journal comes FDA approved 45 new drugs in 2015—a new recent record
It’s a great way to start the New Year: FDA’s Center for Drug Evaluation and Research (CDER) reports 45 “novel new drugs” were approved in 2015, up from 2014’s 41, and representing a new high not seen since the mid-1990s.
Yay! More drugs!
But then there’s an article from STAT, a health care journal: FDA faulted for failure to track safety issues with drugs already on the market
Most Americans assume that drugs approved by the Food and Drug Administration are safe to take as directed. But safety concerns often arise only after the drugs go on the market, when companies or doctors tell the FDA about cases of patients who have fallen ill or died from their medications.
However, a federal watchdog agency [the Government Accountability Office (GAO)] said the FDA is failing to sufficiently track and publicly disclose instances in such cases.
So we have all these new drugs on the market, with pretty barren track records as to safety, but the government office that is supposed to protect us is failing.
Related story from Forbes: A drug recall that should frighten us all about the FDA
Plus, as Pharmaceutical Commerce raved
60% of CDER’s novel new approvals for 2015 were designated in one or more categories of Fast Track, Breakthrough, Priority Review, or Accelerated Approval.
Fast Track, Breakthrough Therapy, Priority Review and Accelerated Approval are four approval approaches offered by the FDA to speed up the approval process and get drugs to the market faster.
Related story from Fortune: Drugs companies are paying huge sums to fast-track FDA approval
And STAT says
[The GAO] expresses particular concern about the lack of tracking of drugs cleared under two expedited approval programs, which account for about one-quarter of all medicines permitted to go on the market.
“FDA has acknowledged that expediting drug application approvals can pose risks for patients,” GAO investigators wrote, stressing that “postmarket” monitoring for those drugs was especially important.
New-to-market drugs are tricky. Drugs studies are done on relatively small numbers of people, who are usually similar in age, gender or health.
Only after a drug is on the market and prescribed to a lot of patients—of differing ages, gender, weight, health, lifestyles, etc.—do the bad or adverse side effects become widely known.
Related post: The Seven Year Rule
In other words, you’re a guinea pig.
How can you protect yourself from harm?
- Don’t demand a brand new drug because you saw the commercial and assume if it’s new, it’s better. That’s rarely true. Plus, older drugs are usually cheaper.
- If your doctor prescribes a new drug, ask if it’s the only option or if there is an older drug available. Sometimes there isn’t, but ask anyway.
- Ask about non-drug options.
- Take the lowest dose for the shortest period of time. That’s good advice for any drug.
- Take the drug exactly as prescribed (dose and frequency).
- Follow up regularly with your doctor to make sure the drug is working as it is supposed to, and you are not experiencing any ill effects.
- Take a look at the FDA’s MedWatch safety page. Yes, it’s the same government agency that is apparently failing us, but they do make an effort to keep the public informed about safety alerts and drug recalls. It’s not a very patient-friendly site, however, and you might find it difficult to find information on your particular drug.
- Sign up for patient safety alerts with the American Recall Center. You can select which drug or category of drugs to follow, and you will be notified if there is an alert or recall. The Recall Center is basically staffed by attorneys looking for class-action lawsuits, but at least they are motivated to get the information out there. 😕
And if you do suffer from a bad reaction or side effects, definitely report your experience to the FDA via their MedWatch voluntary report page.